A wide variety of implantable medical devices for delivering a therapy or monitoring a physiologic condition have been clinically implanted or proposed for clinical implantation in patients. In some cases, implantable medical devices (IMD) deliver electrical stimulation therapy and/or monitor physiological signals via one or more electrodes or sensor elements, which may be included as part of one or more elongated implantable medical leads. Implantable medical leads are configured to allow one or more electrodes and/or sensors to be positioned at desired locations for sensing or delivery of stimulation. For example, electrodes or sensors are positioned at a distal portion of the lead and a connector is positioned at a proximal portion of the lead and coupled to an implantable medical device housing, which may contain electronic circuitry such as stimulation generation and/or sensing circuitry.
For example, implantable medical devices, such as cardiac pacemakers or implantable cardioverter defibrillators, provide therapeutic stimulation to the heart by delivering electrical therapy signals, such as pulses for pacing, or shocks for cardioversion or defibrillation, via electrodes of one or more implantable leads. In some cases, such an implantable medical device senses for intrinsic depolarizations of the heart, and controls the delivery of such signals to the heart based on the sensing. Upon detection of an abnormal rhythm, such as bradycardia, tachycardia or fibrillation, for example, an appropriate electrical signal or signals may be delivered to restore the normal rhythm. For example, in some cases, an implantable medical device delivers pacing, cardioversion, or defibrillation signals to the heart of the patient upon detecting ventricular tachycardia, and delivers defibrillation electrical signals to a patient's heart upon detecting ventricular fibrillation. Pacing signals typically have a lower energy than the cardioversion or defibrillation signals.
Pacing signals, cardioversion signals and defibrillation signals may affect tissue and nerves outside of the target tissue. For example, a pacing pulse applied to the left ventricle may also result in unintended phrenic nerve stimulation (PNS). In other examples, an electrical lead may be placed proximate to the phrenic nerve and provide stimulation designed to stimulate the phrenic nerve. During cardiac stimulation, PNS may cause unpleasant side effects for a patient, such as hiccups, dyspnea, uncomfortable muscle twitching and general malaise. PNS may also decrease the hemodynamic response to cardiac resynchronization therapy (CRT), or generally impair the hemodynamic performance of the heart, in the patient. When implanting a pacemaker, including lead placement, and setting pacing parameters (e.g., choosing the strength of stimulus), a physician or other clinician may attempt to detect and avoid PNS. In other instances, PNS may be provided as an additional therapy option for certain patients with a respiratory disorder.
Unintentional PNS has been reported in as many as 24% of patients with implanted CRT devices. Observation of PNS in hospitalized patients indicates that some instances of unintentional PNS are asymptomatic, e.g., not perceived by the patient or detectable via routine observation of the patient. Unintended movements of the diaphragm can be confirmed through fluoroscopy in the absence of recognizable symptoms for the patient. Although asymptomatic PNS may not lead to obvious side effects such as hiccups, it may still affect the hemodynamics of a patient.